BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4019532 · Received August 19, 2014

    Report

    Report Number
    2531779-2014-23743
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 10/09/2014-PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX REVEALED UNEXPLAINED REBOOTING EVENTS. NO DAMAGE WAS OBSERVED TO THE BATTERY COMPARTMENT AND BATTERY CAP. THE BATTERY CAP CONTACT DIMENSIONS WERE WITHIN SPECIFICATION. THE BATTERY CAP WAS ABLE TO BE PROPERLY SECURED TO THE PUMP. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. NO EVIDENCE OF DAMAGE OR DEFECT WAS FOUND TO THE PUMP¿S INTERNAL COMPONENTS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE WAS BETWEEN 250-499 MG/DL WITHOUT SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE REPORTED BLOOD GLUCOSE EXCURSION DOES NOT MEET CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497336 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR